MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION VERCISE GENUS?; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	DB-1416
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Battery Problem (2885)
Health Effect - Clinical Codes	Speech Disorder (4415); Unspecified Musculoskeletal problem (4535)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximation - based on the date the manufacturer became aware of the event.Block d2b: additional applicable product code: nhl.The device was retained by the facility and not returned for analysis; therefore, a technical analysis could not be performed.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A labeling review did not reveal any anomalies and states that failure or malfunction of any part of the device, including but not limited to: battery leakage, battery failure, lead or lead extension breakage, hardware malfunctions, loose connections, electrical shorts or open circuits, and lead insulation breaches, whether or not these problems require device removal and/or replacement, loss of adequate stimulation, speech or language problems and weakness, muscle spasms, shaking, restlessness, or problems with movement.Also states that, when the implanted non-rechargeable stimulator is nearing the end of its battery life, the stimulator will enter the elective replacement mode.The elective replacement indicator (eri) will appear, and the stimulator must be replaced to continue receiving stimulation; all of which are known risks associated with the use of the deep brain stimulation (dbs) system.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported that a deep brain stimulation (dbs) patient underwent an implantable pulse generator (ipg) revision procedure due to the device reaching end of service (eos).The patient has limited verbal communication and exhibited symptoms including difficulty with mobility and stiffness.Postoperatively, the patient is recovering as expected.The explanted device will not be returned for analysis, as it was retained by the facility.

• Brand Name: VERCISE GENUS?
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 25773605
• Report Number: 3006630150-2026-04820
• Device Sequence Number: 9633343
• Product Code: MHY
• UDI-Device Identifier: 08714729985020
• UDI-Public: (01)08714729985020(17)240507(10)210347
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/07/2024
• Device Model Number: DB-1416
• Device Catalogue Number: DB-1416
• Device Lot Number: 210347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 07/09/2026
• Date Device Manufactured: 05/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female